Venous valve, system, and method

• US 20060282157A1
• Filed: 06/10/2005
• Published: 12/14/2006
• Est. Priority Date: 06/10/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Kokate, Jaydeep Y., Shoemaker, Susan M., Hill, Jason P.
• Granted Patent: US 8,012,198 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Claims

1. A venous valve, comprising:

a frame having a first leaflet connection region and a second leaflet connection region, wherein the first leaflet connection region and the second leaflet connection region include a radial support member; and

a cover on the frame, the cover connected to at least the first leaflet connection region and the second leaflet connection region to provide a first leaflet and a second leaflet having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve.

2. The venous valve of claim 1, wherein the support member includes a tubular ring, where the tubular ring moves radially with the first leaflet connection region and the second leaflet connection region.

3. The venous valve of claim 2, wherein the tubular ring includes a zigzag configuration.

4. The venous valve of claim 1, wherein the first leaflet connection region and the second leaflet connection region provide a first vertex and a second vertex, respectively, relative a first end of the frame.

5. The venous valve of claim 4, wherein the frame includes an outer surface defining a first frame dimension at the first end of the frame and a second frame dimension between the first vertex and the second vertex of the frame, where the second frame dimension is larger than the first frame dimension.

6. The venous valve of claim 5, wherein the outer surface of the frame radially arcs from the first frame dimension to the second frame dimension so as to provide the radial support member of the frame.

7. The venous valve of claim 1, wherein the first leaflet connection region and the second leaflet connection region are positioned opposite each other along a common axis.

8. A venous valve, comprising:

a frame including an outer surface and an inner surface opposite the outer surface and defining a lumen, wherein the frame further includes a radial support member; and

a cover over at least the inner surface of the frame, wherein the cover extends to at least a first leaflet connection region and a second leaflet connection region on the frame adjacent the radial support member to form a first valve leaflet and a second valve leaflet, the first valve leaflet and the second valve leaflet having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen.

9. The venous valve of claim 8, wherein the support member includes a tubular ring, where the tubular ring moves radially with the first leaflet connection region and the second leaflet connection region.

10. The venous valve of claim 9, wherein the tubular ring includes a zigzag configuration.

11. A venous valve, comprising:

a frame having a first vertex and a second vertex relative a first end of the frame, the frame having an outer surface defining a first frame dimension at the first end of the frame and a second frame dimension between the first vertex and the second vertex of the frame, where the second frame dimension is larger than the first frame dimension, wherein the outer surface of the frame radially arcs from the first frame dimension to the second frame dimension so as to provide the radial support member of the frame; and

a cover on the frame, the cover connected to the first vertex and the second vertex to provide a first leaflet and a second leaflet having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve.

12. The venous valve of claim 11, wherein the first vertex and the second vertex are positioned opposite each other along a common axis.

13. The venous valve of claim 11, wherein the cover on the frame includes the cover over an outer surface of the frame.

14. The venous valve of claim 13, wherein the cover on the frame includes the cover over an inner surface of the frame, wherein the cover extends to at least the first vertex and the second vertex on the frame to form the first valve leaflet and the second valve leaflet.

15. The venous valve of claim 11, wherein the frame moves between a collapsed state and an expanded state.

16. A system, comprising:

a venous valve, wherein the venous valve includes;

a frame having a first leaflet connection region and a second leaflet connection region, wherein the first leaflet connection region and the second leaflet connection region include a radial support member;

a cover on the frame, the cover connected to at least the first leaflet connection region and the second leaflet connection region to provide a first leaflet and a second leaflet having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve; and

a catheter including a proximal end and a distal end, the venous valve located between the proximal end and distal end of the catheter.

17. The system of claim 16, wherein the support member includes a tubular ring, where the tubular ring moves radially with the first leaflet connection region and the second leaflet connection region.

18. The system of claim 17, wherein the tubular ring includes a zigzag configuration.

19. The system of claim 16, wherein the first leaflet connection region and the second leaflet connection region provide a first vertex and a second vertex, respectively, relative a first end of the frame.

20. The system of claim 19, wherein the frame includes an outer surface defining a first frame dimension at the first end of the frame and a second frame dimension between the first vertex and the second vertex of the frame, where the second frame dimension is larger than the first frame dimension.

21. The system of claim 20, wherein the outer surface of the frame radially arcs from the first frame dimension to the second frame dimension so as to provide the radial support member of the frame.

22. The system of claim 16, wherein the first leaflet connection region and the second leaflet connection region are positioned opposite each other along a common axis.

23. The system of claim 16, wherein the catheter includes an elongate body having a lumen longitudinally extending to the distal end, a deployment shaft positioned within the lumen, and a sheath positioned adjacent the distal end, the venous valve positioned at least partially within the sheath and adjacent the deployment shaft, wherein the deployment shaft moves within the lumen to deploy the venous valve.

24. The system of claim 16, wherein the catheter includes an elongate body and a retractable sheath over at least a portion of the elongate body, the venous valve positioned at least partially within the retractable sheath, wherein the retractable sheath moves along the elongate body to deploy the venous valve.

25. The system of claim 16, wherein the catheter includes an inflatable balloon positioned adjacent the distal end and a lumen longitudinally extending in an elongate body of the catheter from the inflatable balloon to the distal end, the inflatable balloon at least partially positioned within a lumen of the venous valve, where the inflatable balloon inflates to deploy the venous valve.

26. A method, comprising:

forming a frame having leaflet connection regions;

providing a radial support member on the frame for the leaflet connection regions;

providing a cover on the frame, the cover connected to the leaflet connection regions to provide at least a first leaflet and a second leaflet of a valve having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve; and

reversibly joining the venous valve and a catheter.

27. The method of claim 26, wherein providing the radial support member includes providing a tubular ring as the radial support member, where the tubular ring moves radially with the first leaflet connection region and the second leaflet connection region.

28. The method of claim 26, wherein the first leaflet connection region and the second leaflet connection region provide a first vertex and a second vertex, respectively, relative a first end of the frame.

29. The method of claim 26, wherein providing the radial support member includes flaring the leaflet connection regions from a first frame dimension to a second frame dimension, where the second frame dimension is larger than the first frame dimension.

30. The method of claim 29, wherein flaring the leaflet connection regions includes radially arcing the first frame dimension to the second frame dimension so as to provide the radial support member of the frame.

31. The method of claim 26, wherein reversibly joining the venous valve and the catheter includes positioning the venous valve at least partially within a sheath of the catheter.

32. The method of claim 31, wherein positioning the venous valve at least partially within a sheath of the catheter include positioning the venous valve adjacent a deployment shaft of the catheter.

33. The method of claim 31, wherein the sheath includes a retractable sheath of the catheter.

34. The method of claim 26, wherein the catheter includes an inflatable balloon, the inflatable balloon at least partially positioned within a lumen of the venous valve;

and

inflating the balloon to deploy the vascular valve.

35. A method, comprising:

positioning at least part of a catheter including a venous valve at a predetermined location, wherein the venous valve includes;

a frame having leaflet connection regions that include a radial support member;

a cover on the frame, the cover connected to the leaflet connection regions to provide at least a first leaflet and a second leaflet having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve; and

deploying the venous valve from the catheter at the predetermined location.

36. The method of claim 35, wherein the venous valve includes a tubular ring as the radial support member, where the tubular ring moves radially with the first leaflet connection region and the second leaflet connection region.

37. The method of claim 35, wherein the leaflet connection regions include a first frame dimension to a second frame dimension, where the second frame dimension is larger than the first frame dimension.

38. The method of claim 35, wherein the frame radially arcs from the first frame dimension to the second frame dimension so as to provide the radial support member of the frame.

39. The method of claim 35, wherein the catheter includes a retractable sheath, the venous valve at least partially housed within the retractable sheath, and deploying the venous valve from the catheter at the predetermined location includes retracting the retractable sheath of the catheter.

40. The method of claim 35, wherein the catheter includes a deployment shaft and a sheath, the venous valve at least partially housed within the sheath adjacent the deployment shaft, and deploying the venous valve from the catheter at the predetermined location includes moving the deployment shaft to deploy the venous valve from the sheath of the catheter.

41. The method of claim 35, wherein the catheter includes an inflatable balloon, the inflatable balloon at least partially positioned within the lumen of the venous valve;

and

deploying the venous valve includes inflating the balloon to deploy the vascular valve.